ISO 14971 training

ISO 14971:2019 Risk Management Requirements Workshop

Course Description
ISO 14971:2019 “Medical devices — Application of risk management to medical devices” defines a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to production and post production use. The goal of ISO 14971 training is to develop a risk management plan that is capable of assessing, evaluating, identifying controls, and monitoring the risks associated with each life-cycle stage.

To help understand ISO 14971:2019 the course will use ISO 24971:2020 “Medical devices— Guidance on the application of ISO 14971” which is a companion document. Tools and techniques described in ISO 24971:2020 will be used to demonstrate how risks can be assessed and evaluated.

Finally, this ISO 14971 training course will review ISO 13485:2016, “Medical devices — Quality management systems —Requirements for regulatory purposes” where the concepts from ISO 14971:2019 and ISO 24971:2020 can be applied.

Who Should Attend
This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to apply risk management tools and techniques utilizing ISO 14971:2019 and ISO 24971:2020.

Learning Objectives
Through training, participants will be able to:

  • Describe the Risk Management Process as defined in ISO 14971:2019
  • Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirements
  • Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
  • Identify and Quantify Risks for their Organization
  • Apply Risk Management Tools and how they align with the Product Life Cycle and requirements in ISO 13485:2016

Course Outline

  • Applicability of ISO 14971:2019
  • Structural Changes of ISO 14971:2019
  • Changes and Additions to ISO 14971:2019
  • Changes and Additions to ISO 24971:2020
  • Detailed Analysis of ISO 14971:2019 with reference ISO 24971:2020 Tools and Techniques
    • Clause 1 – Scope
    • Clause 2 – Normative References
    • Clause 3 – Terms and Definitions
      • Exercise #1 – Terms & Definitions
    • Clause 4 – General Requirements
      • Risk Management Plan – Example
      • Clause 5 – Risk Analysis
      • Clause 6 – Risk Evaluation
        • Tools during Product/Service Life Cycle
          • Exercise #2 – Supplier Risk Assessment (ISO 13485)
      • Clause 7 – Risk Control
        • Control Options
        • Benefit-Risk Examples
      • Clause 8 – Evaluation of Overall Risk
      • Clause 9 – Risk Management Review
        • Overall/Total Residual Risk
        • Risk Management Review
      • Clause 10 – Production and post production activities
  • ISO 13485:2016 and Risk Management
    • Exercise #3 – Risk Application – Customer Complaints
    • Exercise #4 – Training Exercise – Risk
  • ISO 14971:2019 Conclusions

Prerequisites
None

Course Format
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
10:00am-2:00pm (EST) each day

Course Instructors
Ken Campanale – Consultant, Quality and Regulatory Systems


Payment Type:
Date Attending
Name of Attendee(s)
Name of Company



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